
[Federal Register Volume 88, Number 229 (Thursday, November 30, 2023)]
[Notices]
[Pages 83551-83552]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26300]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-2562]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Temporary Marketing 
Permit Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by January 2, 2024.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0133. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three

[[Page 83552]]

White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 
20852, 301-796-8867, [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Temporary Marketing Permit Applications--21 CFR 130.17(c) and (i)

OMB Control Number 0910-0133--Extension

    This information collection request supports FDA regulations found 
in 21 CFR 130.17 (section 130.17). Section 401 of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 341) directs FDA to issue 
regulations establishing definitions and standards of identity (SOIs) 
for food. Under section 403(g) of the FD&C Act (21 U.S.C. 343(g)), a 
food that is subject to a definition and SOI prescribed by regulation 
is misbranded if it does not conform to such definition and SOI. 
Section 130.17 provides for the issuance by FDA of temporary marketing 
permits (TMPs) that enable the food industry to test consumer 
acceptance and measure the technological and commercial feasibility in 
interstate commerce of experimental packs of food that deviate from 
applicable definitions and SOIs. Section 130.17(c) enables the Agency 
to monitor the manufacture, labeling, and distribution of experimental 
packs of food that deviate from applicable definitions and SOIs. The 
information so obtained can be used in support of a petition to 
establish or amend the applicable definition or SOI to provide for the 
variations. Section 130.17(i) specifies the information that a firm 
must submit to FDA to obtain an extension of a TMP. To assist 
respondents with the TMP process, we have developed guidance entitled 
``Temporary Permits for Interstate Shipment of Experimental Packs of 
Food Varying from the Requirements of Definitions and Standards of 
Identity: Guidance for Industry'' (November 2021). This resource can be 
found on our website https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-temporary-permits-interstate-shipment-experimental-packs-food-varying-requirements.
    Description of Respondents: Respondents to this collection of 
information include private sector businesses including institutional 
and/or industrial customers and food industry members such as 
manufacturers, packers, or distributors desiring to apply for a TMP or 
TMP extension.
    In the Federal Register of July 17, 2023 (88 FR 45431), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
    21 CFR section; activity         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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130.17(c); Request for TMP......              13               2              26              25             650
130.17(i); Request for TMP                     1               2               2               2               4
 extension......................
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    Total.......................  ..............  ..............  ..............  ..............             654
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: November 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26300 Filed 11-29-23; 8:45 am]
BILLING CODE 4164-01-P


